Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

Prostatic Neoplasms, Castration-Resistant Clinical Trial

Official title:

Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02803437
• Other study ID #: 18212
• Status: Active, not recruiting
• Start date: July 21, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

Description:

This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.

During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.

The extended follow-up period is to collect bone fractures and survival with post-treatment information after Xofigo under the real-world in Japan.

The results of this study (except of extended follow-up period) have to be submitted to the Japanese regulatory authorities as a part of the reexamination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 334
• Est. completion date: December 31, 2024
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients suffered from CRPC with bone metastases

• Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice.

• Xofigo treatment naïve

Exclusion Criteria:

• Patients treated Xofigo previously

• Patients participating in an investigational program with interventions outside of routine clinical practice

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY 88-8223)
Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events as a measure of safety	Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system	Up to 6 months
Primary	Number of adverse drug reactions as a measure of safety	Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system	Up to 6 months
Secondary	Change in laboratory findings (e.g. ALP, bone markers)		From Baseline up to 6 month
Secondary	Change in analgesic use as a surrogate of pain status		From Baseline up to 6 month
Secondary	Number of patients with bone fractures		Up to 3 years
Secondary	Survival rate		Up to 3 years
Secondary	Post-treatment information	Comprises information of post-treatment medication/ therapy for prostate cancer	Up to 3 years

External Links

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